Audit findings responses

Receiving notice of deficiencies after an audit by a regulator cab require immediate steps be taken. For some companies this will entail major remediation efforts, for others it can mean only needing to address a few relatively minor issues.

How and when to respond to the regulator

How and when you respond to the deficiencies is critical as it will impact your compliance rating and the frequency of re-audit.

The deficiencies will be rated as:

  • Critical
  • Major
  • Other

Companies are given four weeks to respond to the findings. Your response should contain a corrective action plan that addresses each deficiency and includes target dates. The lead auditor will notify you if the corrective action plan has been accepted or rejected.

Organizations can submit multiple responses. If there are deficiencies that can be easily and quickly addressed, then you can respond to these first and send in later responses that address the deficiencies that need more effort.

Providing more information than asked can in our experience provoke more questions and prolong the close out.The regulator will require evidence that you are investigating root causes – which we will ensure are included in your response.

How CiPharma can help

CiPharma can:

  • Help your company use appropriate risk assessment to support your response
  • Consult on what actions need to be taken to address each GMP deficiency
  • Help your organization write the response, ensuring that each deficiency is you adequately addressed, without provoking unwarranted questions.
  • Collect the correct evidence to substantiate the response.
  • Organize a meeting with the regulator to present the response – which may be necessary when there have been several major deficiencies

By carefully managing your company’s response, we help you keep or improve your compliance rating, resulting in longer times between audits.